KETOREX SANWA STANDARDS— 510(k) K903365

Name: FDA 510(k) clearance K903365
Creator: U.S. Food and Drug Administration
Published: 1990-12-20

Substantially Equivalent

Ihara Medics U.S., Inc.

FDA 510(k) clearance K903365 for KETOREX SANWA STANDARDS, Substantially Equivalent on 1990-12-20. Applicant: Ihara Medics U.S., Inc.. Device class: 1.

Clearance details

Applicant: Ihara Medics U.S., Inc.
Product code: Code JIN
Device class: Class 1
Regulation: 21 CFR 862.1435
Advisory panel: Clinical Chemistry
Date received: 1990-07-26
Decision date: 1990-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.